510(k) Report

FDA applicant

Benvenue Medical, Inc.

Santa Clara, CA8 decisions2007–20200 recalls

FDA records 8 decisions for Benvenue Medical, Inc. (Santa Clara, CA) from 2007 to 2020: 8 510(k) clearances. Most are in product codes MAX (Intervertebral Fusion Device With Bone Graft…) and NDN (Cement, Bone, Vertebroplasty). Since 2016 its 510(k)s took a median of 150 days from receipt to decision, against 115 for FDA’s reviews in the same codes and years. Its devices cite 21 predicates, 5 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, orthopedic panel, where it files most

How often FDA has decided Benvenue Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2020

2007: 12014: 32016: 12019: 12020: 2
2007high 3 (2014) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Benvenue Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Benvenue Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MAXIntervertebral Fusion Device With Bone Graft, Lumbar4decisions
  • NDNCement, Bone, Vertebroplasty2decisions
  • OCJSpinal Channeling Instrument, Vertebroplasty1decision
  • NKBThoracolumbosacral Pedicle Screw System1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 150 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 115 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 21 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 20143cite it
  • K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc. · 20192cite it
  • K142023Luna Interbody SystemBenvenue Medical, Inc. · 20142cite it
  • K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 20071cites it
  • K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc. · 20201cites it
  • K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. · 20161cites it

What has FDA decided for it lately?

  • K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc. · 2020
  • K193172Luna XD Ti Interbody Fusion SystemBenvenue Medical, Inc. · 2020
  • K183560Luna 3D GEN2 Interbody Fusion SystemBenvenue Medical, Inc. · 2019
  • K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. · 2016
  • K142023Luna Interbody SystemBenvenue Medical, Inc. · 2014
  • K141141Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
  • K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
  • K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007

All 8 as Benvenue Medical, Inc. →